Throughout this whirlwind two-day event, the panelists addressed the challenges of patient education and uptake, the pharmacovigilance of biosimilars, and how to navigate varying regulatory requirements in the global market. But there were four key messages relayed throughout this conference that are worth noting.
Often, the thought of addressing computer system issues and data integrity evaluations becomes overwhelming to quality personnel, and thus these responsibilities are deferred to members of the IT department. I intend to simplify this topic and share some straightforward actions that firms can take to identify and correct deficiencies.
Roughly 15 to 20 years ago, a number of pharmaceutical companies raised money to employ tobacco technology in drug development. Unfortunately, this rush did not lead to the success many were hoping for. However, the successes of recent players in this space suggest pharma could be entering a new age in plant-based manufacturing.
There are a number of high-profile legal and regulatory decisions poised to shape the biosimilar market in the years to come. But there are also a few important trends developing that could give biosimilar makers the upperhand.
Kyle Bass' use of the Inter Partes Review (IPR) process stole headlines and greatly frustrated pharma players. However, a new case that could reshape the use of IPR currently has pharma innovators and generics/biosimilar makers on edge.
Despite biosimilars’ reputation as cheaper alternatives to costly biologics, Medicare Part D patients likely won’t see great savings — at least not right away. According to a recent Avelare Health report, there are two ways patients could see reduced biosimilar out-of-pocket costs. But one of these solutions could place a big burden on biosimilar manufacturers.
This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.
The biosimilar industry is slowly growing in the U.S, and biosimilar manufacturers have joined forces to create The Biosimilars Forum. What are the goals of The Biosimilars Forum, and what impact has this organization had on this burgeoning market so far?
Are physicians beginning to understand the value of biosimilars? According to a recent survey, there are seven key takeaways about physicians’ perceptions of biosimilars.
Educating physicians is a prime goal in the U.S. in order to ensure biosimilars are prescribed. However, are the U.S.'s emerging biosimilar policies already at risk of alienating physicians?
Although I’ve rarely traveled to shows since we launched Life Science Leader in 2009, I’m not unfamiliar with fulfilling this duty as an editor; I did it for six years prior to focusing exclusively on LSL. Still, there was one element of World Biosimilar Congress that seemed foreign to me — the role of the chairperson Richard DiCicco.
Successful prototyping begins with mechanical design that will operate properly when assembled and will be scalable for volume manufacturing. A working prototype can be a smooth progression if you employ the right resources and processes.
In this paper, we discuss how executing Phase III trials for biosimilars differs from that of New Chemical Entities (NCEs). Sponsors should understand from the outset that they will need to build in additional planning time and adopt tailored strategies for assessing feasibility, selecting sites, recruiting patients, procuring the comparator product, and ensuring the integrity of the study blind.
The U.S. biopharmaceutical market recently experienced a watershed moment: a 21-3 Advisory Committee vote in February 2016 to approve the first monoclonal antibody biosimilar. CT-P13, Celltrion’s biosimilar to Remicade® (infliximab), targets autoimmune diseases, including Crohn’s disease, ulcerative colitis and rheumatoid arthritis.
Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.
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